Home / Recalls / Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical / D-0976-2020

D-0976-2020 Class II Terminated

Recalled by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical — Los Angeles, CA

Recall Details

Product Type
Drugs
Report Date
March 11, 2020
Initiation Date
January 15, 2020
Termination Date
December 7, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

Mitomycin-C (PF) Irrigation Solution, MITOMYCIN-C (PF) 0.5 MG/ML PF SYRINGE, For Intravesicular Use, Freeze, Cytoxic Agent, Preservative Free, Protect From Light, 80 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0812-8

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

Code Information

Lot #: 07082019+52606, Exp 4/3/2020; 07242019+52742, Exp 7/22/2020; 07242019+52745, Exp 7/22/2020; 09112019+52907, Exp 5/31/2020; 11142019+53235, Exp 11/12/2020

Other recalls by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

  • D-0943-2020 Class II — BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone Ac (January 15, 2020)
  • D-0965-2020 Class II — Methionine/Inositol/Choline Injection, METHIONINE/INOSITOL/CHOLINE 25MG/50MG/50M (January 15, 2020)
  • D-0991-2020 Class II — Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE [10ML] CM (January 15, 2020)
  • D-0935-2020 Class II — Alprostadil (prostaglandin E1)150 MCG/ML Injectable, For Intracavernosal Use, Fr (January 15, 2020)
  • D-0956-2020 Class II — Human Chorionic Gonadotropin (hCG) Injection, HCG [10ML] 1000 IU/ML INJECTABLE, (January 15, 2020)
  • D-0966-2020 Class II — Methylcobalamin Injection, METHYLCOBALAMIN [CD] 10MG/100MG/ML INJECTABLE, For IV (January 15, 2020)
  • D-0940-2020 Class II — AscorbiX (Buffered C) Injection, Ascorbix (50ML) 500MG/ML Injectable, For IV, IM (January 15, 2020)
  • D-0982-2020 Class II — Super MIC Injection, SUPER MIC* INJECTABLE, Vitamin Complex, For IM Use, 30 mL (January 15, 2020)
  • D-0955-2020 Class II — Glycine Injection,GLYCINE USP 50MG/ML INJECTABLE, For IV, IM Use,30 mL Multi-d (January 15, 2020)
  • D-0985-2020 Class II — Testosterone Cypionate/Progesterone Injection, TESTOSTERONE CYP/PROGESTERONE [2M (January 15, 2020)